There was an internist in a local hospital who thought he knew that Lisette de Bruijn secretly ate bitterballen at night. How could she not lose weight despite a strict diet? Crying, she left his consulting room. Because she had tried everything, every diet, every advice, even intensive exercise with a personal trainer. ‘A lot of people have become very rich because of me,’ she says.
It had started after the pregnancy of her youngest daughter: the record number of kilos that had been gained in those nine months, no matter what she did. The doctor told her after her umpteenth visit that she had to accept that. ‘But I thought that being overweight was really terrible and it also limited me. I remember a visit to Duinrell with my daughter, she wanted to ride the troll train. Mama, you don’t fit in that, she said, and that made me so sad. That she already knew that, no matter how small she was.’
After a six-year search, she ended up at the Healthy Weight Center in Erasmus MC in Rotterdam. She weighed 110 pounds, her BMI (weight divided by height squared) was 41, diagnosis: morbid obesity. There she heard that she was eligible for a new drug, liraglutide, which she only had to pay for herself. Now, three years later, she has lost 25 pounds. Every morning she injects herself with a lancing device that mimics the action of intestinal hormones, which apparently do not function well in her.
She spent about 7,000 euros on the medicine, and there are many more patients who have been paying for liraglutide out of their own pocket for years, says internist-endocrinologist and professor Liesbeth van Rossum (Erasmus MC). ‘Then I will refuel once a month, I sometimes hear them say. That is not desirable, of course, so a form of elite medicine can arise.’
This will change from this month, at least for a small group of patients with a BMI from 35, the group for whom the medicinal refuge is sufficient according to the Zorginstituut. This is the first time in the Netherlands that an anti-obesity drug is reimbursed from the basic insurance. Costs: 2,600 euros per person per year. Two other medicines, which are more user-friendly, are in the waiting room at the Zorginstituut. It is a pill and a product that only needs to be injected once a week (and a pill form of which is now also being tested).
The reimbursement of those drugs could well change the perception of obesity. Although the World Health Organization and the Dutch Health Council already define obesity as a disease, this is still far from being recognized by everyone, obesity experts say. The other way around is also possible, says Anushka Minnaard, chairman of Dikke Vinger, a foundation that defends the interests of fat people: ‘The outside world often thinks that it is our own fault that we are fat and that will only get worse. Because now there is a medicine, so now no one has to be fat anymore.’ Lisette de Bruijn knows those reactions: nice and easy, losing weight at the expense of society.
But it’s not easy at all, she says. To keep those 25 kilos off, she follows a strict diet and moves above average. The drug is also not a quick solution, Van Rossum emphasizes. People who are obese and want to lose weight (permanently) often do not have enough willpower, she explains. The body has the biological urge to return to the old situation and then a medicine can just give you that boost.
A slimming aid is worth gold to the industry
The pharmaceutical industry has been searching for a weight-loss drug for more than half a century. Diets often have little effect in the long run, a stomach reduction is an extreme option. The combined lifestyle intervention, in which people start eating healthy and exercising more with the help of a lifestyle coach, does not result in sufficient weight loss for everyone.
A slimming aid is worth gold to the industry. Because the market is huge and growing: 30 percent of the world’s population (more than 2 billion people) is overweightThe number of obese people (with a BMI of 30 or higher) has doubled in 40 years. In the Netherlands this concerns 14 percent of adults.
Anti-obesity drugs had a bad reputation for a long time. Many substances that came on the market in recent decades were removed after a few years after serious side effects were revealed† Hopes are now pinned on a new class of drugs that mimic incretins (bowel hormones). These substances have an effect in the brain, says Gijs Goossens, obesity researcher at Maastricht UMC: there they inhibit appetite and stimulate the feeling of satiety.
Van Rossum knows patients with a severely disturbed feeling of hunger, in whom the signals of satiety from the gut are not properly received in the brain. “Sometimes this drug really gives them their lives back.”
With Lisette de Bruijn, the daily injection cranks up her slow metabolism, but the 25 kilos she lost as a result are exceptional. In the four studies to liraglutide that the Danish pharmaceutical company had performed, the participants (with an average BMI of 39) lost on average slightly less than 5 percent of their body weight, about 6 kilos, compared to the placebo group. It should be noted that there were outliers: almost a quarter of the participants lost more than 10 percent of their weight thanks to the drug.
Only patients who are extremely overweight are reimbursed for the medicine, as they run the greatest health risk. They must then follow an intensive lifestyle intervention program.
For some of the patients, the weight loss is associated with side effects: in the studies, two-thirds of the participants suffered from nausea and diarrhea, which was sometimes a reason to stop taking it (and thus may have distorted the results). The medicine does not work equally well for everyone, that often becomes clear quickly. The practice has already been adapted to this, says Van Rossum: if the weight loss is insufficient after three months, the treatment is discontinued.
‘The pharmaceutical should simply follow the participants for five years’
Like any other medicine, the anti-obesity drug should ultimately lead to health gains. Overweight people have an increased risk of many diseases, including cardiovascular disease, type 2 diabetes and certain cancers. If they lose weight, the risk of those diseases will decrease. All kinds of biochemical processes in the body run better with a 5 percent weight loss, according to American research that was published in the professional journal Cell Metabolism†
Sounds logical, says Rutger Middelburg, clinical epidemiologist at the Leiden LUMC, but whether this also leads to fewer heart attacks or cancer diagnoses, for example, has not yet been demonstrated for the new drug. Long-term research is needed for this, the Zorginstituut writes in the report about the drug, and therefore indirect evidence is used: a weight loss of at least 5 percent compared to the placebo drug is sufficient. While that doesn’t even get you close to a healthy weight, says Middelburg.
This is remarkable, he thinks, because without hard evidence about health benefits, costs and benefits cannot be weighed against each other. ‘It’s not a bad idea that you get healthier when you lose weight, but you have to prove it. The pharmaceutical company simply has to follow the participants in the study for five years and show them how they are doing.’ The results presented in the report of the National Health Care Institute do not give Middelburg reassurance: after three years of use, the drug has no clinically relevant effect on cholesterol and blood pressure and no effect on quality of life, the average weight loss is probably too low for that. .
There is one exception. Liraglutide is originally an antidiabetes drug, it stabilizes the glucose level in the body. Of the obese patients taking the drug, far fewer participants developed type 2 diabetes. In obese patients who already had diabetes at baseline and were at high risk for cardiovascular disease, the number of strokes and heart attacks in the drug group decreased by 1.9 percentage points compared to the placebo group. The bottom line, says Middelburg, is that fifty obese patients have to take the drug for four years to prevent one death or serious illness. ‘A hefty investment.’
It is understandable that diabetes patients can benefit from the drug, says Middelburg: too much sugar in the blood is bad for the blood vessels. But what does that mean for all obese patients without diabetes? ‘I suspect that the health gain for them will be even smaller.’
While liraglutide, and this has already been shown, in the long run increases the risk of gallstones, inflammation of the gallbladder and the pancreas. Animal experiments show an increased risk of cancer, but that suspicion has never been substantiated in humans. Nevertheless, clinical epidemiologist Middelburg is somewhat hesitant, given the history with previous weight loss drugs.
‘But if we have clear indications that the drug reduces the risk factors for type 2 diabetes and cardiovascular disease, should we wait until we can determine with certainty that fewer heart attacks occur, for example?’, responds obesity researcher Goossens. ‘Of course we need to map out the long-term effects in patients, but I think that the drug has more advantages than disadvantages in some of the obese patients.’
‘I’m not going to expose my body to this’
Nevertheless, chairman Anushka Minnaard of the Dikke Vinger foundation does not think about using the anti-obesity drug. ‘With 10 kilos less, I don’t suddenly have the guarantee that I won’t get heart problems or cancer. Fat and thin, unhealthy and healthy, it’s not black and white, it’s much more complex. When I go to the doctor, I always get comments about my weight first, but there are so many other things that affect my health.’
She has delved into the scientific research, she says, and that has not convinced her. ‘Just like with a diet, this medicine won’t work for the rest of your life. And then those side effects and the unknown long-term risks. I’m not going to expose my body to that.’ The medicine is a topic of discussion within her organization, she says. ‘I understand that there are fat people who want to use it and we don’t reject that either. But I don’t think losing weight is necessary for all of us.’
‘I think it’s great when fat people are satisfied with their bodies, but I couldn’t accept it,’ says Lisette de Bruijn. ‘I was really unhappy. I was checked, always had to defend myself, when I went shopping I never found clothes that fit me.’ They will have to continue to use the obesity drug for life, because stopping, according to the research figures, means that the kilos are quickly regained. Logical, says Van Rossum, because obesity is a chronic disease.
Lisette de Bruijn was informed by her doctor about the possible side effects, but she did not hesitate. ‘If I weigh 140 kilos without medication, what will be the long-term consequences for my health?’ The color in her life is back, she says. If she now goes to Duinrell with her children, she will fit in the troll train.